What should I know about receiving FERAHEME? Before receiving FERAHEME, tell your healthcare provider about all of your medical conditions, including if you: • Have allergies to many different medicines • Have iron overload • Have low blood pressure (hypotension) • Are pregnant or plan to become pregnant. It is not known if FERAHEME will harm your unborn baby • Are breastfeeding or plan to breastfeed. It is not known if FERAHEME passes into your breast milk. You and your healthcare provider should decide if you will receive FERAHEME or breastfeed For IDA in adults Tell your healthcare provider about all the medicines you take, including prescription and over- 2 doses* 3-8 days apart the-counter medicines, vitamins, and herbal supplements. FERAHEME® is a prescription medicine used to treat iron deficiency anemia in adults who have: For eligible patients with financial • Intolerance to oral iron or who have not responded need, support may be available. well to treatment with oral iron or Talk to your doctor to find out more. • Chronic kidney disease (CKD) IMPORTANT RISK INFORMATION Please read the Patient Information and see FERAHEME may cause serious side effects the full Prescribing Information in pocket. including: Serious allergic reactions that can lead to death. Serious allergic reactions have happened in people after receiving the first dose of FERAHEME or after receiving additional doses in people who did not previously have an allergic reaction. If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to FERAHEME. Please read the Patient Information and see the full Prescribing Information in pocket. *Some patients may require additional courses of therapy. What is iron deficiency WhatWhat should is FERAHEME I know about A treatment that fits anemia (IDA)? receiving(ferumoxytol FERAHEME injection)? your schedule IDA is a common type of anemia caused by too little iron in FERAHEMEBefore receiving is a prescriptionFERAHEME ,medicine tell your FERAHEME allows for a flexible the body. Iron is a mineral that is part of hemoglobin. When healthcare provider about all of your you don’t have enough iron, your body cannot make the used to treat iron deficiency anemia in treatment schedule medical conditions, including if you: hemoglobin it needs, and this causes anemia. adults who have: FERAHEME is given in 2 doses as an IV infusion by a • IntoleranceHave allergies to oralto many iron or different who have medicines not responded well healthcare provider or nurse. Causes and common symptoms of IDA • toHave treatment iron overload with oral iron or • The IV infusion will take at least 15 minutes • Chronic kidney disease (CKD) • The second dose is given 3 to 8 days after the first Common causes of IDA include chronic kidney disease • Have low blood pressure (hypotension) (CKD), gastrointestinal disorders that cause loss of blood • Are pregnant or plan to become pregnant. It is not It is not known if FERAHEME is safe and effective in Your healthcare provider will watch you during the infusion or interfere with absorbing iron, loss of blood, not enough known if FERAHEME will harm your unborn baby iron in the body, abnormal uterine bleeding or inflammation children less than 18 years of age. and for at least 30 minutes after you receive FERAHEME. • Are breastfeeding or plan to breastfeed. It is not in the body, and/or poor diet. known if FERAHEME passes into your breast milk. Tell your healthcare provider or get The most common symptom of anemia is fatigue You and yourWho healthcare should provider should not decide if you (feeling very tired). will receive FERAHEME or breastfeed medical help right away if you get any receive FERAHEME? of these signs or symptoms: For IDA in adults Tell your healthcare provider about all the 2 doses* 3-8 days apart What tests will my healthcare provider use medicines you take, including prescription and over- • Rash the-counter medicines, vitamins, and to see if I have IDA? • Itching Doherbal not supplements. receive FERAHEME if you: A complete blood count (CBC) test measures your • Dizziness or lightheadedness FERAHEME® is a prescription medicine used to treat hematocrit and hemoglobin (Hgb) levels. Low levels of • Are allergic to FERAHEME or any of the ingredients • Swelling of the tongue or throat iron deficiency anemia in adults who have: in FERAHEME. The ingredients in FERAHEME are either can signal iron deficiency anemia. For eligible patients with financial • Wheezing or trouble breathing • Intolerance to oral iron or who have not responded ferumoxytol and mannitol well to treatment with oral iron or Your healthcare provider may also test your ferritin and need, support may be available. • Have had an allergic reaction to any iron medicine given transferrin saturation levels. Talk to your doctor to find out more. See “What are the possible side effects of FERAHEME?” • Chronic kidney disease (CKD) into your vein by intravenous (IV) infusion on the back panel for more information about side effects. IDA may be associated with other diseases and conditions. IMPORTANT RISK INFORMATION Talk with your healthcare provider about all possible Please read the Patient Information and see Please read the Patient Information and see Please read the Patient Information and see FERAHEME may cause serious side effects causes of IDA. the full Prescribing Information in pocket. the full Prescribing Information in pocket. the full Prescribing Information in pocket. including: Serious allergic reactions that can lead to death. Serious allergic reactions have happened in Key terms to know people after receiving the first dose of FERAHEME or after receiving additional doses in people who did not Hemoglobin: The protein in red blood cells (RBCs) that previously have an allergic reaction. If you have a history carries oxygen throughout the body. of allergies to many different medicines, you may have an increased risk of serious allergic reactions to FERAHEME. Hematocrit: The volume of RBCs in the blood. Ferritin: The protein that stores iron in your body. Please read the Patient Information and see Transferrin: The protein that transports iron throughout the full Prescribing Information in pocket. the body. *Some patients may require additional courses of therapy. ©2018 AMAG Pharmaceuticals, Inc. All rights reserved PP-FRH-US-00059 PP-FRH-US-00059 reserved rights All Inc. Pharmaceuticals, AMAG ©2018 material are registered trademarks of AMAG Pharmaceuticals, Inc. Pharmaceuticals, AMAG of trademarks registered are material AMAG Pharmaceuticals, Feraheme, and the logo designs presented in this this in presented designs logo the and Feraheme, Pharmaceuticals, AMAG AMAG Pharmaceuticals, Inc. 1100 Winter Street Waltham, MA 02451 MA Waltham, Street Winter 1100 Inc. Pharmaceuticals, AMAG 1-800-FDA-1088. effects. You may report side effects to FDA at at FDA to effects side report may You effects. Call your doctor for medical advice about side side about advice medical for doctor your Call . FERAHEME of effects side possible the of all not are These or hands. or arms, feet, legs, your of swelling and constipation, include: diarrhea, headache, nausea, dizziness, dizziness, nausea, headache, diarrhea, FERAHEME of effects side common most The FERAHEME tests to check your iron levels during treatment with with treatment during levels iron your check to tests Iron overload Iron . Your healthcare provider will do blood blood do will provider healthcare Your . • infusion infusion FERAHEME each check you for signs and symptoms of hypotension after after hypotension of symptoms and signs for you check sometimes be serious. 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If you have a history of allergies to to allergies of history a have you If reaction. allergic an additional doses in people who did not previously have have previously not did who people in doses additional receiving the first dose of FERAHEME or after receiving receiving after or FERAHEME of dose first the receiving Serious allergic reactions have happened in people after after people in happened have reactions allergic Serious Serious allergic reactions that can lead to death. to lead can that reactions allergic Serious • side effects, including: effects, side serious cause can FERAHEME ? ) injection ferumoxytol ( FERAHEME of effects side possible the are What What is iron deficiency What is FERAHEME A treatment that fits anemia (IDA)? (ferumoxytol injection)? your schedule IDA is a common type of anemia caused by too little iron in FERAHEME is a prescription medicine FERAHEME allows for a flexible the body. Iron is a mineral that is part of hemoglobin. When you don’t have enough iron, your body cannot make the used to treat iron deficiency anemia in treatment schedule hemoglobin it needs, and this causes anemia. adults who have: FERAHEME is given in 2 doses as an IV infusion by a • Intolerance to oral iron or who have not responded well healthcare provider or nurse. Causes and common symptoms of IDA to treatment with oral iron or • The IV infusion will take at least 15 minutes • Chronic kidney disease (CKD) • The second dose is given 3 to 8 days after the first Common causes of IDA include chronic kidney disease (CKD), gastrointestinal disorders that cause loss of blood or interfere with absorbing iron, loss of blood, not enough It is not known if FERAHEME is safe and effective in Your healthcare provider will watch you during the infusion iron in the body, abnormal uterine bleeding or inflammation children less than 18 years of age. and for at least 30 minutes after you receive FERAHEME.